European court ruling raises hurdles for CRISPR crops

Hopes for an easier regulatory road for genetic engineering in European agriculture were dashed today by the Court of Justice of the European Union. In a closely watched decision, the court ruled that plants created with new gene-editing techniques that don’t involve transferring genes between organisms—such as CRISPR—must go through the same lengthy approval process as traditional transgenic plants.

Many researchers had argued that regulators should take a lighter touch when evaluating products created with the new technologies, but environmental groups and their allies successfully argued that they should be subject to the same EU rules that apply to other genetically modified organisms.

“We applaud the European Court of Justice for this forward-thinking decision,” said Dana Perls, senior food and agriculture campaigner at Friends of the Earth (FOE) in Washington, D.C., in a statement. “All products made with genetic engineering, including ones made with gene-editing tools like CRISPR, should be regulated, assessed for health and environmental impacts, and labeled.” FOE’s affiliate in France was part of a coalition of groups that brought the case.

The ruling is “the death blow for plant biotech in Europe,” said Sarah Schmidt of the Heinrich Heine University of Düsseldorf in Germany. It will force gene-edited plants to go through a regulatory process that typically costs about $35 million, she said, meaning only large companies will be able to foot the bill, effectively pricing out universities, nonprofits, and small companies.

The case focused on crops that have been made resistant to herbicides without transferring genes from other species. (The transgenic technique has been the typical way of creating herbicide-tolerant crops.) The French government had passed a law exempting these new gene-edited crops from regulation under the European Union’s directive on genetically modified organisms (GMOs), which requires an assessment of risks to health and the environment, as well as labeling, tracking, and monitoring of the products. Confédération Paysanne, a French union in Bagnolet representing small farms, and eight other groups, sued and charged that the plants modified with gene-editing techniques should be regulated under the GMO directive, because they could cause significant harm.

The court decided that gene-editing techniques are covered by the GMO directive because they “alter the genetic material of an organism in a way that does not occur naturally.” (The court exempted conventional mutagenesis—the unnatural use of chemicals or radiation to create mutations for plant breeding—because it has “a long safety record.”) It also said the new gene-editing techniques have risks that could be similar to those of transgenic engineering.

Those findings drew criticism from some researchers. “To classify gene-edited crops as GMOs and equivalent to transgenic crops is completely incorrect by any scientific definition,” said Nick Talbot, a molecular geneticist at the University of Exeter in the United Kingdom. “Precise modern gene-editing technologies allow accurate, predictable changes to be made in a genome.”

The court also asserted that gene-editing techniques “make it possible to produce genetically modified varieties at a rate out of all proportion to those resulting from the application of conventional methods of mutagenesis.” Schmidt said she was “shocked” by this claim. Maurice Moloney, CEO of the Global Institute for Food Security in Saskatoon, Canada, called it “logically absurd” that gene editing was riskier than the random mutagenesis used in conventional breeding.

In its statement, FOE said it hopes U.S. regulators would follow the lead of the European court. So far, however, U.S. officials have said they have no plans to subject most gene-edited crops to the same regulatory process used for transgenic crops.